ISO 9001 Auditing Practices Group - Guidance on Auditing Includes 9001:2015 Material

Sidney Vianna

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Peter Fraser said:
Sidney

It is good to know that someone is attempting to explain all this, but ...
"Easy to understand"? Try:
"If an auditee cannot distinguish between the concepts of a process and an activity, the auditor can briefly explain the differences by using the guidance (clause 2.4) ..."

Clause 2.4 says: "Any activity, or ..., that uses resources to transform inputs to outputs can be considered as a process".

So how clever does the auditor have to be to explain that a process can be an activity, but that they are also different? (Clause 3..4.1 then goes on to contradict the definition in Clause 2.4).

Not a lot of help to anyone who is struggling to understand what ISO9001:2000 means or how to apply it, I don't think!

Just to make sure that people understand it: I simply copied the press release from the ISO website. I read the documents and I agree that some of the advice there is confusing and some advice is weak, in my personal opinion.
As you can tell, there are some documents missing in the website.

Concerns like these are the basis for my disagreement with the approach taken by ISO and the TC 176 in being involved with interpreting the Standard, creating advice documents and so on. To this date, I received no reply from the TC 176 about what many people in this forum thought was a bad interpretation. I am referring to the one that states that suppliers are not required to inform the customer when they have shipped non-conforming products. :mad:

And yes, I had posted the same link, earlier in the year
 

Sidney Vianna

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More advice from the APG

Sidney Vianna said:
The documents are being developed by the ISO 9001:2000 Auditing Practices Group (APG) established by ISO (International Organization for Standardization) and the IAF (International Accreditation Forum - www.iaf.nu) - the grouping of national accreditation bodies that verify the competence of certification bodies. The documents are available on the APG Web site at: *** DEAD LINK REMOVED*** - WAS isotc176sc2.elysium-ltd.net / APG_index.html
Just to share with you all that the Audit Practice Group keep populating the site with more documents concerning good practices for auditors. Some of the most recent ones are:
·Auditing Internal Communications

·Auditing Preventive Action

·Auditing Service Organizations

·Third Party Auditor Impartiality and Conflict of Interest

·Auditing the Effectiveness of the Internal Audit

·Auditing Electronic Based Management Systems

For the whole set, point your browsers to https://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/138403/3541460/customview.html?func=ll&objId=3541460&objAction=browse&sort=name
 
E

edyie

Sidney Vianna said:
*** DEAD LINK REMOVED ***

Ref.: 905
29 March 2004

ISO offers free-of-charge ISO 9001:2000 'auditing kit'
Twenty guidance modules on specific aspects of auditing ISO 9001:2000 quality management systems (QMS) are available free of charge from ISO and another three are being developed.

Short, easy to read and understand, the guidance modules that make up the "auditing kit" adopt a practical, "how to" approach. They have been developed mainly for certification body personnel carrying out audits of quality systems for organizations seeking an ISO 9001:2000 certificate as independent confirmation of their implementation of ISO's well-known standard.

However, they may also be useful to staff carrying out in-house audits to provide assurance to management about the performance of their organization's quality system, as well as to consultants, trainers and anyone with an interest in quality.

The guidance modules are not endorsed by ISO and are not a product of its standards-development processes. The documents are intended to provide additional assistance to ISO 9001:2000 users, without modifying any of the requirements of the standard.

The documents are being developed by the ISO 9001:2000 Auditing Practices Group (APG) established by ISO (International Organization for Standardization) and the IAF (International Accreditation Forum - www.iaf.nu) - the grouping of national accreditation bodies that verify the competence of certification bodies. The documents are available on the APG Web site at: *** DEAD LINK REMOVED*** - WAS isotc176sc2.elysium-ltd.net / APG_index.html

The 20 documents so far developed by the APG address the following specific issues in ISO 9001:2000 auditing:

The need for a two-stage approach to auditing
Measuring QMS effectiveness and improvements

Identification of processes

Understanding the process approach

Determination of the "where appropriate" processes

Auditing the "where appropriate" requirements

Demonstrating conformity to the standard
Linking an audit of a particular task, activity or process to the overall system
Auditing continual improvement
Auditing a QMS which has minimum documentation
How to audit top management processes
The role and value of the audit checklist
Scope of ISO 9001:2000, scope of QMS and defining scope of certification
Value-added auditing
Auditing competence and the effectiveness of actions taken
Effective use of ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
Auditing statutory and regulatory requirements
Auditing quality policy and quality objectives
Auditing the control of monitoring and measuring devices.
The APG recently agreed to develop additional documents on the three following topics:


Auditing customer satisfaction
Writing nonconformities that are understandable, useful and therefore add value
Reviewing responses to nonconformities to assure correction and corrective action that is effective.
A link to the documents on the APG Web site is provided too in the ISO 9000 section on ISO's main Web site. This section also includes the latest versions of the free-of-charge documents comprising the ISO 9000:2000 Introduction and Support Package - another initiative by ISO to facilitate the understanding and implementation of its quality system standards. In addition, the section has a wide choice of free sample articles from ISO's bimonthly magazine ISO Management Systems, which provides a worldwide overview of the ISO 9000 and ISO 14000 families of quality and environmental management standards, including implementation case studies, survey, analyses, viewpoints and debates.

Press contact:
Roger Frost
Press and Communication Manager
Public Relations Services
Tel. +41 22 749 01 11
Fax +41 22 733 34 30
Sidney, Could you please tell me the web site where you found the free ISO audit kit? Thank you, Edyie
 

Wes Bucey

Prophet of Profit
Re: ISO offers free-of-charge ISO 9001:2000 'auditing kit'

I want to add a special shoutout to Sidney for consistently supplying links to credible official sites for details and insight into interpretations of ISO Standards clauses and methods and techniques of auditing those Standards which can be used by in-house auditors as well as third party auditors.
 
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M Greenaway

Re: ISO offers free-of-charge ISO 9001:2000 'auditing kit'

I dont really understand quite what the point is of the 'output matters' article, other than what the title says - output does of course matter.

What we are looking for in a quality system however are 'systematic' methods (processes if you like) that deliver the required output.

The article appears to dissmiss things like the importance of calibration during an audit, and other such details of the QMS - personally I think this is foolhardy.

Lets not forget the overriding purpose of any 'style' of quality management is to prevent things going wrong, i.e. it is proactive in putting in place systems that will prevent us making mistakes, it is not reactive to outputs of systems when we do make mistakes. Therefore one of the objectives of audit to ensure that those preventive measures are effective and are being operated is a very valid and important management tool.

It appears that the article suggests we revert to old style QC inspection routines with our audit programme, and just measure output - so long as its OK, based on a very limited sample that we observe today, then why worry about how it was achieved - ridiculous !!!!!!!!!!!!
 

Colin

Quite Involved in Discussions
Re: ISO offers free-of-charge ISO 9001:2000 'auditing kit'

I don't really understand quite what the point is of the 'output matters' article, other than what the title says - output does of course matter.

What we are looking for in a quality system however are 'systematic' methods (processes if you like) that deliver the required output.

The article appears to dismiss things like the importance of calibration during an audit, and other such details of the QMS - personally I think this is foolhardy.

Lets not forget the overriding purpose of any 'style' of quality management is to prevent things going wrong, i.e. it is proactive in putting in place systems that will prevent us making mistakes, it is not reactive to outputs of systems when we do make mistakes. Therefore one of the objectives of audit to ensure that those preventive measures are effective and are being operated is a very valid and important management tool.

It appears that the article suggests we revert to old style QC inspection routines with our audit programme, and just measure output - so long as its OK, based on a very limited sample that we observe today, then why worry about how it was achieved - ridiculous !!!!!!!!!!!!

I understand your view on this but I read it to be encouraging auditors to look at the 'product' or output of processes and not just the processes themselves. I think that ISO 9001 auditors have (rightly) been criticised in the past for just verifying that the organisation has procedures and is working to them rather than looking at the effectiveness of the system in achieving conforming product and satisfied customers.
 
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M Greenaway

Re: ISO offers free-of-charge ISO 9001:2000 'auditing kit'

OK so long as we 'dont throw the baby out with the bathwater' on this one I think.

I had a similar chat some time ago with an auditor who works for one of the major certification bodies in the UK. I questioned with him are we losing sight of important processes, such as drawing control and calibration, under the new 'process approach' of ISO9001 and more critically the new perception of 'process auditing' that seems to be permeating the industry. He replied that well under an ISO9001 QMS you would have a process measure (KPI) that should indicate if calibration or document control issues were actually causing you real problems.

Like I say I feel this totally loses the 'preventive' emphasis of any QMS, and indeed the preventive tool that an audit can, and I believe should be.

Also I think it would be impossible to drill down from an overall KPI of lets say percentage returns to be able to conclude it was due to calibration issues.
 

gpainter

Quite Involved in Discussions
Re: ISO offers free-of-charge ISO 9001:2000 'auditing kit'

Good information. Thanks to all!
 
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